FDA 510(k) clearances — page 1204
clearances on record, most recent first.
Clearances — page 1204
120,301–120,400 of 175,890- K913754 — CARDIO 500
- K913895 — FLO-GARD(R) 6200, 6300 & 8000
- K914073 — F21(R) DENTAL CEMENT
- K914074 — 8000 SERIES VOLUMETRIC PUMP SOLUTION SET
- K914261 — ABBOTT QUICKSTART LD-1,#5A30
- K914418 — ACT-II BEHIND THE EAR HEARING AID
- K914477 — AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
- K910541 — BIOKIT RPR
- K911144 — MF-500, MODIFICATION
- K911465 — INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
- K912116 — PRESSURE SORE MANAGEMENT KIT
- K912436 — AM-PAK
- K912445 — MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
- K912635 — ANNULUS DISPOSABLE VALVULOTOME
- K912636 — ANNULUS VALVULOTOME
- K912894 — AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
- K913245 — MODEL 80 HEARING AID DISPENSING SYSTEM
- K913246 — HYBRID FIT TOTAL HIP SYSTEM
- K913383 — OXYGEN MASKS 81420, 81421, 81471 & 81461
- K913399 — QBC E-Z PREP
- K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589
- K913480 — WOUND CARE TRAY A
- K913729 — POLAR PUMP, MODEL 500
- K913783 — CORDIS PTCA GUIDING CATHETER, MODIFICATION
- K913861 — HEMOCHRON(R) KACT
- K913967 — DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
- K914007 — CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
- K914182 — GOLDEN THERMAL(R)
- K910693 — PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
- K911383 — HOTLINE FLUID WARMER
- K911650 — PEDIA PALS
- K912144 — SIMON NITINOL FILTER, MODIFICATION
- K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
- K912589 — AVI MODEL 840D DUAL CHANNEL INFUSION PUMP
- K912590 — AVI MODEL 400D INFUSION PUMP
- K913017 — MODULEX RTP SYSTEM
- K913076 — I.V. INSTANT TIMER
- K913083 — BI-TEMP TEMPERATURE MONITOR TM-201D
- K913141 — MEGA MYELOGRAM KIT
- K913271 — OSTEO BONE PLATED
- K913288 — MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
- K913569 — COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
- K913655 — PROBASE HOT AND PROBASE COLD
- K913761 — 3-D ACCUSCAN FACIAL IMPLANTS
- K913802 — AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER
- K913832 — AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER
- K913836 — VLC GLASS IONOMER
- K914130 — AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES
- K914254 — HOMECLINIC ONE STEP PREGNANCY TEST
- K914304 — FIRST RESPONSE(R) ONE-STEP
- K914400 — MODELS E2502B/E2525 REUSABLE HANDSWITCHING PENCILS
- K904893 — FIAX LYME M TEST KIT
- K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
- K910884 — CARD GUARD, MODELS CG-6000 & CG-7000
- K911455 — MODEL #100 SHOCK-TRODE CHILD DEFIB PADS
- K911456 — MODEL #110 STEALTH-TRODE CHILD DEFIB PADS
- K911869 — IVT GUIDING CATHETER
- K912063 — POLARIS, ORAL INDICATION
- K912621 — MODEL #911 STEALTH MULTI PADS
- K913191 — DORNIER LASER LITHOTRIPTER IMPACT
- K913193 — MODEL 100 CENTRAL STATION
- K913600 — WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM
- K913689 — SUB-4(TM), PERIPHERAL DILATATION CATHETER
- K913801 — CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
- K904360 — CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR
- K905672 — TEAM-MC
- K910421 — SATURATION/HEMATOCRIT MONITOR SYSTEM
- K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE
- K911598 — DATASCOPE PASSPORT MONITOR
- K911750 — COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED
- K911770 — OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
- K911814 — AXION 5, MODIFICATION
- K911888 — PHILIPS ANGIOPRO
- K911983 — WIZARD STERILIZED ELECTROEPILATION NEEDLE
- K912033 — ULTRASOUND STETHOSCOPE(R) INTRADOP(R)
- K912412 — VITALOGRAPH SPIROTRAC III
- K912684 — HOME MEDICAL KIT - FOR LITTLE HURTS
- K912710 — TRUE/FLEX TIBIAL RODS WITH CAP
- K912763 — OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)
- K912933 — MEDICAM LAPAROSCOPY ENDOSCOPES
- K913029 — GYROVIEW-HR
- K913148 — COLLAGEN SHIELD FOR ACUTE CARE
- K913189 — NIDEK MODEL NT-1000
- K913461 — FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM
- K913478 — RADIOGRAPHIC FILM MARKING SYSTEM
- K913619 — CERAVITAL MIDDLE EAR IMPLANT
- K913745 — DUCAL SIDE SHIELD SUNGLASS
- K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
- K910341 — POLARIS
- K910687 — GUARDIAN GEL, SURGEON'S GLOVING CREAM
- K911925 — POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU
- K912107 — GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
- K912255 — HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
- K912330 — B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
- K912344 — MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS
- K912369 — HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
- K912370 — HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
- K912703 — OPTICA 60 ND; YAG SURGICAL LASER SYSTEM
- K913060 — NATURAL POROUS HIP SYSTEM
- K913188 — KINEMAX PLUS TIBIAL INSERT
Data sourced from openFDA. This site is unofficial and independent of the FDA.